Fresenius USA, Inc.

FDA 510(k) & PMA Approved Devices — 38 products

Total Devices38

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K992275	FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS	KDI	1999-08-04	View
510(k)	K970700	FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX	MSE	1998-09-15	View
510(k)	K974584	FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS	KDI	1998-05-14	View
510(k)	K973378	C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61	CAC	1997-11-03	View
510(k)	K961465	2008H ON LINE CLEARANCE MONITOR	KDI	1997-07-03	View
510(k)	K961706	P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR	LKN	1996-07-31	View
510(k)	K955762	PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	KPF	1996-07-31	View
510(k)	K941460	FRESENIUS BLOOD TEMPERATURE MONITOR	MQS	1996-07-03	View
510(k)	K955423	PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	FKP	1996-06-13	View
510(k)	K944767	DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER	FIP	1995-11-29	View
510(k)	K930181	BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE	FKP	1995-11-29	View
510(k)	K922088	FRESENIUS DIALYSATE ACID CONCENTRATE	KPO	1994-10-17	View
510(k)	K926005	FRESENIUS HEMOFLOW, VARIOUS MODELS	FJI	1994-08-23	View
510(k)	K921456	FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM	FKP	1994-04-20	View
510(k)	K922005	GRANULYTE DIALYSATE CONCENTRATE	KPO	1994-03-30	View
510(k)	K921134	FRESENIUS POLYSULFONE DIALYZERS	KDI	1993-12-02	View
510(k)	K915634	FRESENIUS PD+ EXCHANGE DEVICE	EKX	1993-07-01	View
510(k)	K921052	FRESENIUS VARIABLE FILL MONITOR	KDJ	1993-02-25	View
510(k)	K912208	FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE	KDJ	1991-07-24	View
510(k)	K911459	GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING	KPO	1991-07-17	View